Trial Outcomes & Findings for Dexmedetomidine Versus Midazolam for Facilitating Extubation (NCT NCT00744380)
NCT ID: NCT00744380
Last Updated: 2016-09-28
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
23 participants
Primary outcome timeframe
Duration of ICU stay, for up to 24 weeks
Results posted on
2016-09-28
Participant Flow
Participant milestones
| Measure |
Midazolam
Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4) as other sedatives are down titrated. Daily awakenings are used.
Midazolam: Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)
|
Dexmedetomidine
Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)as other sedatives are down titrated. Daily awakenings are used.
Dexmedetomidine: Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
11
|
|
Overall Study
COMPLETED
|
12
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Dexmedetomidine Versus Midazolam for Facilitating Extubation
Baseline characteristics by cohort
| Measure |
Midazolam
n=12 Participants
Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4) as other sedatives are down titrated. Daily awakenings are used.
Midazolam: Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)
|
Dexmedetomidine
n=11 Participants
Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)as other sedatives are down titrated. Daily awakenings are used.
Dexmedetomidine: Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.8 years
STANDARD_DEVIATION 9.3 • n=99 Participants
|
58.3 years
STANDARD_DEVIATION 15.3 • n=107 Participants
|
58.1 years
STANDARD_DEVIATION 13.5 • n=206 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Weight
|
105.2 kg
STANDARD_DEVIATION 40.9 • n=99 Participants
|
100.8 kg
STANDARD_DEVIATION 37.4 • n=107 Participants
|
103 kg
STANDARD_DEVIATION 38.5 • n=206 Participants
|
|
Acute Physiologic And Chronic Health Evaluation III Score
|
70.4 units on a scale
STANDARD_DEVIATION 33.5 • n=99 Participants
|
74.1 units on a scale
STANDARD_DEVIATION 18.2 • n=107 Participants
|
72.8 units on a scale
STANDARD_DEVIATION 25 • n=206 Participants
|
|
Primary Diagnosis
Respiratory failure
|
5 participants
n=99 Participants
|
5 participants
n=107 Participants
|
10 participants
n=206 Participants
|
|
Primary Diagnosis
Sepsis
|
5 participants
n=99 Participants
|
4 participants
n=107 Participants
|
9 participants
n=206 Participants
|
|
Primary Diagnosis
Other
|
2 participants
n=99 Participants
|
2 participants
n=107 Participants
|
4 participants
n=206 Participants
|
|
Time in ICU before qualifying
|
1.1 days
n=99 Participants
|
1.2 days
n=107 Participants
|
1.1 days
n=206 Participants
|
|
Time from qualifying to randomization
|
1 days
n=99 Participants
|
0.7 days
n=107 Participants
|
0.9 days
n=206 Participants
|
|
Baseline Sedative
Midazolam
|
10 participants
n=99 Participants
|
6 participants
n=107 Participants
|
16 participants
n=206 Participants
|
|
Baseline Sedative
Lorazepam
|
2 participants
n=99 Participants
|
5 participants
n=107 Participants
|
7 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Duration of ICU stay, for up to 24 weeksPopulation: The analysis only includes patients successfully extubated for at least 72 hours. Eight subjects were excluded.
Outcome measures
| Measure |
Midazolam
n=8 Participants
Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4) as other sedatives are down titrated. Daily awakenings are used.
Midazolam: Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)
|
Dexmedetomidine
n=7 Participants
Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)as other sedatives are down titrated. Daily awakenings are used.
Dexmedetomidine: Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)
|
|---|---|---|
|
Time From Study Drug Initiation to Tracheal Extubation
|
2.9 days
Interval 2.0 to 4.4
|
3.4 days
Interval 2.6 to 14.2
|
SECONDARY outcome
Timeframe: Duration of ICU stay, for up to 24 weeksOutcome measures
| Measure |
Midazolam
n=12 Participants
Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4) as other sedatives are down titrated. Daily awakenings are used.
Midazolam: Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)
|
Dexmedetomidine
n=11 Participants
Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)as other sedatives are down titrated. Daily awakenings are used.
Dexmedetomidine: Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)
|
|---|---|---|
|
Cumulative Doses of Conventional Sedatives and Analgesics
Open-label midazolam while on study drug
|
29 mg
Interval 18.8 to 48.9
|
65.3 mg
Interval 24.5 to 92.3
|
|
Cumulative Doses of Conventional Sedatives and Analgesics
All midazolam whil eon study drug
|
126.9 mg
Interval 93.2 to 608.8
|
65.3 mg
Interval 24.5 to 92.3
|
|
Cumulative Doses of Conventional Sedatives and Analgesics
All fentanyl while on study drug
|
5.4 mg
Interval 3.5 to 9.2
|
4.1 mg
Interval 3.0 to 14.0
|
SECONDARY outcome
Timeframe: Duration of ICU stay, for up to 24 weeksThe Riker sedation-agitation score (range 1-7) and PABS (range 0-10) are assessed hourly by the bedside nurse. Riker scores assess restlessness and cooperation. Riker scores of 5 - 7 indicate agitation, 3 - 4 represent adequate sedation and 1 - 2 represent excessive sedation. PABS assessments include domains of restlessness, muscle tone, vocalization, consolability, and facial expressions. PABS assessments of 0 represent no pain, 1 - 3 represent mild pain, 4 - 6 represent moderate pain, and ≥ 7 represent severe pain.
Outcome measures
| Measure |
Midazolam
n=12 Participants
Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4) as other sedatives are down titrated. Daily awakenings are used.
Midazolam: Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)
|
Dexmedetomidine
n=11 Participants
Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)as other sedatives are down titrated. Daily awakenings are used.
Dexmedetomidine: Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)
|
|---|---|---|
|
The Quality of Sedation (Assessed by the Riker Sedation-Agitation Score) and Analgesia (Assessed by the Pain Assessment Behavioral Score)
Riker score 3-4 while on study drug
|
84.1 percentage of assessments while on study
|
71.2 percentage of assessments while on study
|
|
The Quality of Sedation (Assessed by the Riker Sedation-Agitation Score) and Analgesia (Assessed by the Pain Assessment Behavioral Score)
Riker score 5-7 while on study drug
|
6.6 percentage of assessments while on study
|
27.1 percentage of assessments while on study
|
|
The Quality of Sedation (Assessed by the Riker Sedation-Agitation Score) and Analgesia (Assessed by the Pain Assessment Behavioral Score)
Pain score > 3 while on study drug
|
13.3 percentage of assessments while on study
|
21.4 percentage of assessments while on study
|
|
The Quality of Sedation (Assessed by the Riker Sedation-Agitation Score) and Analgesia (Assessed by the Pain Assessment Behavioral Score)
Riker score 1-2 while on study drug
|
5.4 percentage of assessments while on study
|
4.1 percentage of assessments while on study
|
SECONDARY outcome
Timeframe: Duration of ICU stay, up to 24 weeksOutcome measures
| Measure |
Midazolam
n=12 Participants
Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4) as other sedatives are down titrated. Daily awakenings are used.
Midazolam: Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)
|
Dexmedetomidine
n=11 Participants
Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)as other sedatives are down titrated. Daily awakenings are used.
Dexmedetomidine: Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)
|
|---|---|---|
|
Sedation-related Adverse Effects
Hypotension
|
6 participants
|
10 participants
|
|
Sedation-related Adverse Effects
Bradycardia
|
7 participants
|
7 participants
|
|
Sedation-related Adverse Effects
Tachycardia
|
5 participants
|
7 participants
|
|
Sedation-related Adverse Effects
Delirium, new onset
|
5 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Duration of hospital stay, up to 24 weeksPopulation: Only subjects capable of performing the ICU-SEQ were provided the assessment. Seven subjects were excluded.
The ICU-SEQ assesses patient recall of their ICU experience. The ICU-SEQ assesses both psychological (e.g. fearfulness, anxiety) and physical (e.g. pain, difficulty breathing) perceptions of ICU patients who have received mechanical ventilation. It consists of 29 potentially stressful experiences with seven items specifically addressing the endotracheal tube. The extent that patients are bothered by each item is scored on a five point scale: 0 = "not at all," 1 = "a little bit," 2 = "moderately," 3 = "quite a bit," and 4 = "extremely." The cumulative score is an integer interpreted as interval data with higher scores indicating greater stressful experiences associated with the ICU. The minimum score is 0 and the maximum score possible is 116.
Outcome measures
| Measure |
Midazolam
n=8 Participants
Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4) as other sedatives are down titrated. Daily awakenings are used.
Midazolam: Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)
|
Dexmedetomidine
n=8 Participants
Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)as other sedatives are down titrated. Daily awakenings are used.
Dexmedetomidine: Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)
|
|---|---|---|
|
ICU Experiences by Administering ICU Stressful Experiences Questionnaire (ICU-SEQ)
|
8.5 units on a scale
Interval 0.0 to 29.0
|
18.5 units on a scale
Interval 0.0 to 29.0
|
SECONDARY outcome
Timeframe: Duration of ICU stay, up to 24 weeksOutcome measures
| Measure |
Midazolam
n=12 Participants
Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4) as other sedatives are down titrated. Daily awakenings are used.
Midazolam: Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)
|
Dexmedetomidine
n=11 Participants
Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)as other sedatives are down titrated. Daily awakenings are used.
Dexmedetomidine: Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)
|
|---|---|---|
|
Duration of Study Drug Administration
|
3 days
Interval 0.8 to 5.1
|
3.5 days
Interval 2.0 to 4.9
|
SECONDARY outcome
Timeframe: Duration of hospital stay, up to 24 weeksPopulation: Only subjects capable of performing the IES-R were provided the assessment. Seven subjects were excluded.
The IES-R evaluates subjective distress caused by traumatic events and assesses manifestations of post-traumatic stress disorder (PTSD) or acute stress disorder. It is not diagnostic but possesses excellent reliability and validity for manifestations of PTSD. The IES-R has three subscales (eight items on intrusion, eight items on avoidance, and six items on hyperarousal). Each item is scored on a four point scale: 0 = "not at all," 1 = "a little bit," 2 = "moderately often," 3 = "quite a bit," and 4 = "extremely often." The total score of each subscale may be averaged and a cumulative score of 30 is indicative of the presence of PTSD. The maximum score for each subscale is 32 for intrusion, 32 for avoidance, and 24 for hyperarousal. The minimum cumulative score is 0 and the maximum cumulative score possible is 88.
Outcome measures
| Measure |
Midazolam
n=8 Participants
Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4) as other sedatives are down titrated. Daily awakenings are used.
Midazolam: Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)
|
Dexmedetomidine
n=8 Participants
Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)as other sedatives are down titrated. Daily awakenings are used.
Dexmedetomidine: Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)
|
|---|---|---|
|
Manifestations of Acute Stress Disorder by Impact of Event Scale - Revised (IES-R)
|
13 units on a scale
Standard Deviation 12
|
36 units on a scale
Standard Deviation 12
|
SECONDARY outcome
Timeframe: Duration of hospital stay, up to 24 weeksPopulation: Only subjects capable of performing the HADS were provided the assessment. Seven subjects were excluded.
The HADS consists of 14 questions, seven for anxiety and seven for depression. Each item is scored from 0 to 3, with a cut-off cumulative score of 11 for both subscales indicative of anxiety or depression. This scoring tool has been used for 30 years, possesses excellent reliability and validity, and avoids reliance conditions that are also common somatic symptoms of illness such fatigue, insomnia, and hypersomnia. The maximum score for each subscale is 21 with a maximum possible cumulative score of 42. The minimum score for each subscale is 0. The minimum cumulative score is 0
Outcome measures
| Measure |
Midazolam
n=8 Participants
Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4) as other sedatives are down titrated. Daily awakenings are used.
Midazolam: Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)
|
Dexmedetomidine
n=8 Participants
Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)as other sedatives are down titrated. Daily awakenings are used.
Dexmedetomidine: Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)
|
|---|---|---|
|
Hospital Anxiety and Depression Scale (HADS) Score
Anxiety
|
3 units on a scale
Standard Deviation 3.1
|
6 units on a scale
Standard Deviation 7.6
|
|
Hospital Anxiety and Depression Scale (HADS) Score
Depression
|
6 units on a scale
Standard Deviation 6.7
|
4 units on a scale
Standard Deviation 5.3
|
Adverse Events
Midazolam
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Dexmedetomidine
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Midazolam
n=12 participants at risk
Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4) as other sedatives are down titrated. Daily awakenings are used.
Midazolam: Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)
|
Dexmedetomidine
n=11 participants at risk
Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)as other sedatives are down titrated. Daily awakenings are used.
Dexmedetomidine: Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)
|
|---|---|---|
|
Nervous system disorders
Acute Neurologic Encephalopathy
|
0.00%
0/12
|
9.1%
1/11 • Number of events 1
|
Other adverse events
| Measure |
Midazolam
n=12 participants at risk
Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4) as other sedatives are down titrated. Daily awakenings are used.
Midazolam: Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)
|
Dexmedetomidine
n=11 participants at risk
Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)as other sedatives are down titrated. Daily awakenings are used.
Dexmedetomidine: Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)
|
|---|---|---|
|
Cardiac disorders
Hypotension
|
50.0%
6/12 • Number of events 6
|
90.9%
10/11 • Number of events 10
|
|
Cardiac disorders
Bradycardia
|
58.3%
7/12 • Number of events 7
|
63.6%
7/11 • Number of events 7
|
|
Cardiac disorders
Tachycardia
|
41.7%
5/12 • Number of events 5
|
63.6%
7/11 • Number of events 7
|
|
Nervous system disorders
Delirium, new onset
|
41.7%
5/12 • Number of events 5
|
45.5%
5/11 • Number of events 5
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place